The safety assessments included recording of frequency of adverse events (AEs) and discontinuations of treatment. Sample size and data analysis Sample size was based on practical considerations rather than on statistical. were evaluated at week 24. Results A total of 978 of 1 1,931 enrolled patients (mean age: 72.8 years; 50.5% female) were in the transdermal Clemizole hydrochloride cohort. For patients with exposure to both oral and transdermal monotherapy (n=330), a significant caregivers preference for the transdermal Clemizole hydrochloride monotherapy was observed (82.7%; em P /em 0.0001). Of the 89 participating physicians, 71 indicated preference for transdermal monotherapy. Patient compliance was also significantly higher for transdermal than oral monotherapy ( em P /em 0.0001). Conclusion Our study showed higher caregiver and physician preference and greater patient compliance with transdermal monotherapy in daily practice. strong class=”kwd-title” Keywords: rivastigmine, Alzheimers disease, cholinesterase inhibitors, patient compliance, observational study, transdermal patch Introduction Alzheimers disease (AD), a progressive neurodegenerative disorder, accounts for up to 75% of all dementia cases.1 Worldwide, more than 35 million people live with AD, and this number is expected to double by 2030 and reach 115 million by 2050. 2 The progression of symptoms in patients with AD can be delayed by early and aggressive treatment management;3,4 however, patient compliance to treatment remains a challenge.5 As the disease progresses, patients with AD require increased assistance from their caregivers. Caregivers, especially family members, play a key role in the care and treatment compliance of patients with AD.5,6 The currently approved oral symptomatic treatments for AD are donepezil, galantamine, rivastigmine (cholinesterase inhibitors), and memantine ( em N /em -methyl-d-aspartate receptor antagonist).7 Rivastigmine is also available as a transdermal formulation that provides continuous delivery over 24 hours and results in fewer side effects compared with oral rivastigmine.8,9 The efficacy and safety of the rivastigmine transdermal formulation have been demonstrated in various randomized controlled trials.10C13 However, there is limited literature available on the caregiver and physician treatment preference and patient compliance with transdermal rivastigmine in a real-world clinical setting.14C17 To date, no such study is available in patients from Asia and the Middle East, despite this part of the world accounting for a sizeable proportion of patients with AD. The present study was designed to evaluate the treatment preference and compliance in an ethnically diverse population from Asia and the Middle East with mild-to-moderate AD treated with oral (cholinesterase inhibitors or memantine) or transdermal monotherapy (rivastigmine patch) in a real-world clinical Clemizole hydrochloride setting. Patients in this study were treated according to the usual Clemizole hydrochloride care and not by the protocol. This study reports real-world evidence. Clemizole hydrochloride The real world characterizes the fact that data collected in this study originated from the routine medical care of patients. Patients and methods Study design RECAP (Real-world Evaluation of Compliance And Preference in the treatment of Alzheimers disease) was a 24-week, multicenter, prospective, noninterventional study conducted at 92 participating sites in India (24 sites), Egypt (34 sites), South Korea (15 sites), Taiwan (9 sites), Lebanon (8 sites), and Singapore (2 sites) between March 2011 and July 2013 (Figure 1). Patients were invited to participate as they were prescribed a capsule or a transdermal patch therapy by their treating physician for AD. The patients participated in this study after providing written informed consent, or where applicable, such consent provided by a legally acceptable representative of the patient. The eligible patients were grouped into one of the two treatment cohorts according to the route of administration of the AD medication taken at the study entry: oral (donepezil, galantamine, rivastigmine, or memantine) or transdermal (rivastigmine). The observational period for each participant was 24 weeks (8 weeks). Data were collected at three time points: study access (baseline), week 12 (4 weeks), and week 24 (8 weeks; end of the study). Open in a separate window Number 1 Patient disposition. Notes: A patient having completed appointments up to visit 3 (week 24) was regarded as having completed the study. Aligning with the definition of noninterventional study (Article 2[c] EU Directive 2001/20/EC),18 the medications under observation were prescribed in compliance with the marketing authorization, and the treatment decision was made as part of individuals typical medical care and before study participation. No diagnostic or monitoring methods, in addition to typical care, were performed. Study participation included completion of the Caregiver Medication Questionnaire (CMQ) at the end of the study. The CMQ included questions derived from AD Caregiver Preference Questionnaire (ADCPQ) that was psychometrically validated using data from the IDEAL (Investigation of transDermal Exelon in ALzheimers disease) study.13,19,20 The.The CMQ included questions on patient compliance and satisfaction with treatment, general preference (oral versus transdermal treatment), and top three reasons for treatment preference. (n=330), a significant caregivers preference for the transdermal monotherapy was observed (82.7%; em P /em 0.0001). Of the 89 participating physicians, 71 indicated preference for transdermal monotherapy. Patient compliance was also significantly higher for transdermal than oral monotherapy ( em P /em 0.0001). Summary Our study showed higher caregiver and physician preference and greater patient compliance with transdermal monotherapy in daily practice. strong class=”kwd-title” Keywords: rivastigmine, Alzheimers disease, cholinesterase inhibitors, patient compliance, observational study, transdermal patch Intro Alzheimers disease (AD), a progressive neurodegenerative disorder, accounts for up to 75% of all dementia instances.1 Worldwide, more than 35 million people live Rat monoclonal to CD8.The 4AM43 monoclonal reacts with the mouse CD8 molecule which expressed on most thymocytes and mature T lymphocytes Ts / c sub-group cells.CD8 is an antigen co-recepter on T cells that interacts with MHC class I on antigen-presenting cells or epithelial cells.CD8 promotes T cells activation through its association with the TRC complex and protei tyrosine kinase lck with AD, and this quantity is expected to double by 2030 and reach 115 million by 2050.2 The progression of symptoms in individuals with AD can be delayed by early and aggressive treatment management;3,4 however, patient compliance to treatment remains challenging.5 As the disease progresses, individuals with AD require increased assistance from their caregivers. Caregivers, especially family members, play a key part in the care and treatment compliance of individuals with AD.5,6 The currently approved oral symptomatic treatments for AD are donepezil, galantamine, rivastigmine (cholinesterase inhibitors), and memantine ( em N /em -methyl-d-aspartate receptor antagonist).7 Rivastigmine is also available like a transdermal formulation that provides continuous delivery over 24 hours and results in fewer side effects compared with oral rivastigmine.8,9 The efficacy and safety of the rivastigmine transdermal formulation have been demonstrated in various randomized controlled trials.10C13 However, there is limited literature available on the caregiver and physician treatment preference and patient compliance with transdermal rivastigmine inside a real-world clinical setting.14C17 To date, no such study is available in patients from Asia and the Middle East, despite this part of the world accounting for any sizeable proportion of patients with AD. The present study was designed to evaluate the treatment preference and compliance in an ethnically varied human population from Asia and the Middle East with mild-to-moderate AD treated with oral (cholinesterase inhibitors or memantine) or transdermal monotherapy (rivastigmine patch) inside a real-world medical setting. Patients with this study were treated according to the typical care and not from the protocol. This study reports real-world evidence. The real world characterizes the fact that data collected with this study originated from the routine medical care of individuals. Patients and methods Study design RECAP (Real-world Evaluation of Compliance And Preference in the treatment of Alzheimers disease) was a 24-week, multicenter, prospective, noninterventional study carried out at 92 participating sites in India (24 sites), Egypt (34 sites), South Korea (15 sites), Taiwan (9 sites), Lebanon (8 sites), and Singapore (2 sites) between March 2011 and July 2013 (Number 1). Patients were invited to participate as they were prescribed a capsule or a transdermal patch therapy by their treating physician for AD. The individuals participated with this study after providing written knowledgeable consent, or where relevant, such consent provided by a lawfully suitable representative of the patient. The eligible individuals were grouped into one of the two treatment cohorts according to the route of administration of the AD medication taken at the study entry: oral (donepezil, galantamine, rivastigmine, or memantine) or transdermal (rivastigmine). The observational period for each participant was 24 weeks (8 weeks). Data were collected at three time points: study access (baseline), week 12 (4 weeks),.